PMID- 35975180
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220818
IS  - 1179-7266 (Print)
IS  - 1179-7266 (Electronic)
IS  - 1179-7266 (Linking)
VI  - 13
DP  - 2022
TI  - A Phase IV Study on Safety, Tolerability and Efficacy of Dolutegravir, 
      Lamivudine, and Tenofovir Disoproxil Fumarate in Treatment Naive Adult Indian 
      Patients Living with HIV-1.
PG  - 75-84
LID - 10.2147/POR.S361907 [doi]
AB  - PURPOSE: WHO recommends dolutegravir (DTG) based regimens as first-line treatment 
      for HIV-1 infection. However, few studies have been conducted in Indian 
      population. Hence, our study evaluated the safety, tolerability, and efficacy of 
      DTG 50 mg with Tenofovir and Lamivudine (300/300mg) fixed dose combination in 
      treatment naive adult Indian patients. METHODS: This was an open label, 
      multicenter, prospective, interventional, phase IV study conducted across 14 
      sites between February 2019 and July 2020. 24 weeks was the treatment duration 
      for each subject. The primary end point was to assess the incidence of adverse 
      events (AEs) and secondary end points were to assess the proportion of patients 
      achieving plasma HIV-1 RNA levels <50 copies/mL at week 24 and change in CD4+ 
      cell count from the baseline. Safety analysis was conducted using Safety Analysis 
      Set and efficacy analysis was carried out using Full Analysis Set and Per 
      protocol set. RESULTS: A total of 288 patients were screened; 250 were enrolled; 
      and 229 completed the study. 389 AEs were reported from 58% of patients. Of 
      these, 61 were related to study treatment. One event of decreased creatinine 
      clearance led to study discontinuation. One serious event of pyrexia was 
      reported, which was unrelated to the study drug. The most common AEs were 
      headache (18%), pyrexia (14%), vomiting (6.4%) and upper respiratory tract 
      infections (6%). No deaths were reported. At week 24, 86.8% of the patients 
      achieved plasma HIV-1 RNA levels <50 copies/mL and the mean CD4 cell count 
      increased from 350.2 (SD, 239.73) at baseline to 494.6 (SD, 261.40) with an 
      average increase of 143.2 (SD, 226.14) cells. CONCLUSION: This study demonstrated 
      the safety and efficacy of DTG based regimen in treatment naive HIV-1 patients in 
      Indian population and support use of DTG as first-line treatment regimen.
CI  - (c) 2022 Dravid et al.
FAU - Dravid, Ameet
AU  - Dravid A
AD  - Department of Infectious Diseases and Clinical Research, Poona Hospital and 
      Research Centre, Pune, Maharashtra, India.
FAU - Morkar, Dnyanesh
AU  - Morkar D
AD  - Department of Medicine, KLE's Dr Prabhakar Kore Hospital and MRC, Belagavi, 
      Karnataka, India.
FAU - Prasad, Dwijendra
AU  - Prasad D
AD  - Department of General Medicine, People Tree Hospital 2, Bangalore, Karnataka, 
      India.
FAU - Ramapuram, John T
AU  - Ramapuram JT
AD  - Department of Medicine, Kasturba Medical College Hospital, Mangalore, Karnataka, 
      India.
FAU - Patel, Kartik Vikrambhai
AU  - Patel KV
AD  - Department of Medicine, Kanoria Hospital and Research Centre, Gandhinagar, 
      Gujarat, India.
FAU - Naik, K Sunil
AU  - Naik KS
AD  - Department of General Medicine, Rajiv Gandhi Institute of Medical Sciences and 
      RIMS Government General Hospital, Srikakulam, Andhra Pradesh, India.
FAU - Bhrusundi, Milind
AU  - Bhrusundi M
AD  - Department of Medicine, Lata Mangeshkar Multi Specialty Hospital, Nagpur, 
      Maharashtra, India.
FAU - Kulkarni, Milind
AU  - Kulkarni M
AD  - Department of Medicine, Sahyadri Super Specialty Hospital, Pune, Maharashtra, 
      India.
FAU - Hegde, Sanjeev
AU  - Hegde S
AD  - Department of Global Clinical Operations, Viatris, Bengaluru, Karnataka, India.
FAU - Anuradha, S
AU  - Anuradha S
AD  - Department of Medicine, Maulana Azad Medical College and Associated Lok Nayak, 
      New Delhi, India.
FAU - Nageswaramma, Siddabathuni
AU  - Nageswaramma S
AD  - Department of Dermatology, Guntur Government General Hospital, Guntur, Andhra 
      Pradesh, India.
FAU - Madan, Surabhi
AU  - Madan S
AD  - Department of Clinical Research, Care Institute of Medical Sciences (CIMS) 
      Hospital, Ahmedabad, Gujarat, India.
FAU - Jayaprakash, Thammisetty
AU  - Jayaprakash T
AD  - Department of Pulmonology, Anu Hospitals, Vijayawada, Andhra Pradesh, India.
FAU - Kulkarni, Vinay
AU  - Kulkarni V
AUID- ORCID: 0000-0001-9781-6230
AD  - Department of Dermatology, LMMF's Deenanath Mangeshkar Hospital and Research 
      Center, Pune, Maharashtra, India.
LA  - eng
PT  - Journal Article
DEP - 20220810
PL  - New Zealand
TA  - Pragmat Obs Res
JT  - Pragmatic and observational research
JID - 101688693
PMC - PMC9375976
OTO - NOTNLM
OT  - CD4 cell count
OT  - HIV-1
OT  - adverse events
OT  - dolutegravir
OT  - efficacy
OT  - safety
OT  - viral load
COIS- AD has received financial grants for conducting clinical research from Cipla, 
      Mylan, Emcure and MSD pharma private limited and received fees for being speaker 
      at pharma sponsored seminars and webinars organized by Cipla, Mylan, Emcure, MSD, 
      Genex and Aurobindo pharma private limited. SH is an employee of Viatris, 
      Bangalore, India. All other authors have no competing interests to declare in 
      this work.
EDAT- 2022/08/18 06:00
MHDA- 2022/08/18 06:01
PMCR- 2022/08/10
CRDT- 2022/08/17 02:01
PHST- 2022/02/23 00:00 [received]
PHST- 2022/07/25 00:00 [accepted]
PHST- 2022/08/17 02:01 [entrez]
PHST- 2022/08/18 06:00 [pubmed]
PHST- 2022/08/18 06:01 [medline]
PHST- 2022/08/10 00:00 [pmc-release]
AID - 361907 [pii]
AID - 10.2147/POR.S361907 [doi]
PST - epublish
SO  - Pragmat Obs Res. 2022 Aug 10;13:75-84. doi: 10.2147/POR.S361907. eCollection 
      2022.